Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol. An Equivalence Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colo-rectal Cancer
- Sponsor
- Serveis de Salut Integrats Baix Empordà
- Enrollment
- 630
- Primary Endpoint
- Adenoma detection rate
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The Efficacy and safety of Non-anesthesiologist administered propofol (NAAP) for gastrointestinal endoscopy have been widely documented although there is not information which has evaluated the outcomes of colonoscopy it self when the endoscopist has to fulfill the additional task of supervising the sedation.
Objective: To determine the equivalence of adenoma detection rate (ADR) in colorectal cancer (CRC) screening colonoscopies performed with NAAP and performed with monitored anesthesia care (MAC).
Method: Single blind non-randomized controlled equivalence trial. Patients: Adults between 50 - 69 years old from National CRC screening program (CRCSP). Intervention: The patients are blindly assigned to undergo either colonoscopy with NAAP or MAC according to the arrival of fecal occult blood test, patient's suitability for colonoscopy date and availability of places at endoscopy schedule (with NAAP or MAC).
Investigators
Marco Alburquerque
Head of Gastroenterology Department
Serveis de Salut Integrats Baix Empordà
Eligibility Criteria
Inclusion Criteria
- •Healthy patients -
Exclusion Criteria
- •Patients with familial colorectal cancer history
Outcomes
Primary Outcomes
Adenoma detection rate
Time Frame: 30 days
Percentage of patients aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected and removed